Central European Pediatric Oncology Early Trial Alliance

Regina Demlova

CEPOETA

• A non-profit organization supporting the clinical research in pediatric oncology in CEE region, particularly in the area of innovative clinical trials for children and young adults.

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CEPOETA missions • Create an international framework of experts

on clinical trials in children • Increase the number of multicenter clinical

trials for children with cancer in Central and Eastern Europe.

• Access to new innovative drugs for children with cancer within the EU

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CEPOETA mission

• Intermediate communication and cooperation – state authorities (regulators) – pediatric oncology healthcare facilities – parents and children in the area of pediatric

oncology – Patient organizations

CEPOETA milestoness

June 2015

General Assembly of members, Brno

November 2015 KDO_DC1311

September 2016 ReNETA CZ

May 2017 EnprEMA (level 3)

2017; General Assembly of Members , Cluj-Napoca

April 2018 ReNETA HU, SLO

CEPOETA management • General Assembly • President (Prof. Valik D., former CHMP member) • Council:

– Ass. Prof. Valík – Ass. Prof. Demlová – Dr. Koščík

• Advisory board • Secretary

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CEPOETA Membership Membership in CEPOETA is open to: • legal entities involved in research or provision of healthcare in the

area of pediatric oncology • persons that pursue conduct of clinical studies in the field of

pediatric oncology and other persons that possess relevant knowledge and capacity to support the main activities of CEPOETA

• Currently: Czech Republic, Slovakia, Slovenia, Hungary, Romania,

Macedonia, Bulgaria, Serbia

Membership - Application for membership of association – available in print and on CEPOETA´s website

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CEPOETA meetings

• The members regularly meet on – The Regional Central-Eastern/South-Eastern

European Pediatric Oncohematology Meeting, – The Romanian-Hungarian Pediatric Oncology

Meeting – The Pediatric CELG Meeting

CEPOETA´s website • www.cepoeta.org

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CEPOETA in cooperation with ECRIN-ERIC

WP CZECRINPED MED - Pediatric Clinical Trials

Central European Pediatric Oncology Early Trial Alliance

• Partnership with pediatric investigation networks • Development of tools for pediatric population • Pilot trials on EU/national level

WP CZECRINPED MED

• CZECRIN_4Patients – pediatric research

• ReNETA • KDO_DC113

CEPOETA clinical trials Ongoing CT: • Combined anticancer therapy with ex vivo manipulated Dendritic Cells producing

interleukin-12 in pediatric, adolescent and young adults with progressive recurrent or primary metastatic malignancies of high risk

KDO_DC1311 EUDRA CT number: 2014-003388-39

• Recurent Neuroblastoma and Ewing´s sarcoma: Treosulphan based high dose

chemotherapy with Autologous PBSC support ReNETA study – submitted to national RA, EC EUDRA CT number: 2015-002584-41 Planned CT (2018/2019) • 16-33209A Genome-wide expression profiling and mutation analysis as the diagnostic

basis for personalized pediatric cancer treatment plans: a feasibility study • 16-34083A Receptor tyrosin kinases and downstream signaling pathways as possible

therapeutic targets in pediatric refractory solid tumors

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• CEPOETA created a close collaboration with priority consumers, mainly patients and patients’ groups in public health and health advocacy in CZ and across EU (http://www.koaliceprozdravi.cz; www.lpr.cz; http://www.lymfomhelp.cz/)

• New partnership with iCAN research – CEPOETA initiated process of developing KIDS-Czech Republic for involving children and young people in clinical research in 2018

• Planned partnership TEDDY Network - European Network of Excellence for Paediatric Clinical Research (on process)

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CEPOETA collaboration

CEPOETA as a EnpreEMA

CEPOETA activities Increasing level of expertise of its members in the field of pediatric oncology and pediatric clinical trials in onkology • Focus on keeping clinical research ethical standards • Training course on Pediatric Pharmacovigilance • Development QA/QC management system harmonised in CEE • Clinical Data Management System ( REDCap; OpenClinica) –

implementation of GDPR rules • Study coordinator/study nurses pediatric training programme – in

cooperation with

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THANK YOU